U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Device, Irrigation, Ocular Surgery - Product Code KYG
원인
"please be aware that this is not a new recall. this recall was initially classified in 2005 (z-1595-05). the firm has taken action; but, due to administrative issues this product is now being classified by the agency". foreign deposit present on the surface of the vidaurri lasik flap irrigators.
조치
OASIS Medical shall inform all customers that have received the product via FAX and Certified Mail to cease use immediately and return all unused product to OASIS.
Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland
제품 설명
OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604 Dual Tip Irrigator 8 Ports The Dual tip Irrigator 8 Ports is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is || placed into a Tyvek pouch, heat-sealed and sterilized. After sterilization, 10 pouches are loaded into a carton, the carton is labeled and heat-shrink wrapped.